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Multiply Labs is revolutionizing cell therapy production with ai

Multiply Labs is revolutionizing cell therapy production with robotic systems and AI-driven digital twins.

Multiply Labs is revolutionizing cell therapy production with robotic systems and AI-driven digital twins, cutting costs by up to 70%, increasing throughput, and reducing contamination ri

The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics
Regulatory Science

Oryzon secures EMA approval to start HOPE-2 vafidemstat trial in PMS

Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with
Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Belite Bio to present DRAGON Phase 3 tinlarebant data at Euretina

Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA
Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics
Diagnostics

ITM reports re-treatment and dosimetry data for ITM-11 at ASTRO

Real-world SwissNET registry data showed patients re-treated with 177Lu-edotreotide achieved nearly triple the median overall survival of those switched to
Real-world SwissNET registry data showed patients re-treated with 177Lu-edotreotide achieved nearly triple the median overall survival of those switched to
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biotech

Addex Therapeutics posts H1 2026 loss as cash falls to CHF 0.8m

Addex reported a net loss of CHF 3.5m for the first half of 2026, with cash at CHF 0.8m after an ATM raise
Addex reported a net loss of CHF 3.5m for the first half of 2026, with cash at CHF 0.8m after an ATM raise
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Annexon to present ARCHER II baseline data at Retina Society meeting

Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.
Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject strengthens balance sheet as BARDA deal extended to $48m

The Dijon-based emergency-medicine biotech returned to positive equity after a €15m capital raise, with its BARDA contract now extended through 2030.
The Dijon-based emergency-medicine biotech returned to positive equity after a €15m capital raise, with its BARDA contract now extended through 2030.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Boehringer Ingelheim funds WHO Foundation obesity drive with $5m

The German pharma group will contribute $5 million over three years to strengthen obesity and metabolic health systems in resource-limited settings.
The German pharma group will contribute $5 million over three years to strengthen obesity and metabolic health systems in resource-limited settings.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Pharmaceuticals
Cell & Gene Therapy
Biologics

Penn Medicine and IBA form Noventra Oncology Alliance JV

The joint venture will offer end-to-end advisory and operational support to health systems building or expanding proton therapy programmes worldwide.
The joint venture will offer end-to-end advisory and operational support to health systems building or expanding proton therapy programmes worldwide.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject expands board and hires ex-FDA lead ahead of ZEPIZURE launch

The French specialty pharma firm has added three executives to its board and appointed a former FDA reviewer to lead US regulatory strategy for ZEPIZURE.
The French specialty pharma firm has added three executives to its board and appointed a former FDA reviewer to lead US regulatory strategy for ZEPIZURE.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

Nanobiotix reports NBTXR3 NSCLC data and €86m raise

Nanobiotix posted H1 2026 results showing encouraging NBTXR3 response rates in lung and head and neck cancer trials, backed by a freshly raised €86 million.
Nanobiotix posted H1 2026 results showing encouraging NBTXR3 response rates in lung and head and neck cancer trials, backed by a freshly raised €86 million.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

CARVYKTI gives five-year remissions to 50% in early-line myeloma

Five-year CARTITUDE-2 data show half of early-line RRMM patients remained alive and progression-free after a single cilta-cel infusion, with no
Five-year CARTITUDE-2 data show half of early-line RRMM patients remained alive and progression-free after a single cilta-cel infusion, with no
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

EC approves leriglitazone as first pharmacological cALD treatment

Neuraxpharm and Minoryx win EU marketing authorisation for NEZGLYAL, the first oral drug approved for cerebral adrenoleukodystrophy in young boys.
Neuraxpharm and Minoryx win EU marketing authorisation for NEZGLYAL, the first oral drug approved for cerebral adrenoleukodystrophy in young boys.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Addex regains global GABAB PAM rights after Indivior R&D pullback

Addex Therapeutics has reclaimed its full GABAB positive allosteric modulator portfolio from Indivior, citing the UK firm's R&D rationalisation ahead of a planned
Addex Therapeutics has reclaimed its full GABAB positive allosteric modulator portfolio from Indivior, citing the UK firm's R&D rationalisation ahead of a planned
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Pharming wins FDA Priority Review for Joenja in lighter children

Pharming's sNDA for lower leniolisib doses in children weighing 13-27 kg with APDS has a PDUFA date of 30 January 2027.
Pharming's sNDA for lower leniolisib doses in children weighing 13-27 kg with APDS has a PDUFA date of 30 January 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Elicio Therapeutics AMPLIFY-7P data selected for ESMO 2026 oral slot

Phase 2 KRAS-targeting immunotherapy data will be presented at ESMO Congress in Madrid on 23 October, informing a refined Phase 3 strategy.
Phase 2 KRAS-targeting immunotherapy data will be presented at ESMO Congress in Madrid on 23 October, informing a refined Phase 3 strategy.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Regulatory Science

aTyr Pharma secures FDA alignment on efzofitimod Phase 3 design

aTyr Pharma has agreed a Phase 3 protocol with the FDA for efzofitimod in pulmonary sarcoidosis, with study activities due to begin in Q4 2026.
aTyr Pharma has agreed a Phase 3 protocol with the FDA for efzofitimod in pulmonary sarcoidosis, with study activities due to begin in Q4 2026.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Scancell secures $25m BlackRock debt facility to fund iSCIB1+ Phase 3

The Oxford immuno-oncology company has agreed a structured loan facility with BlackRock to help finance its registrational melanoma trial, due to start by end
The Oxford immuno-oncology company has agreed a structured loan facility with BlackRock to help finance its registrational melanoma trial, due to start by end
The Biotech Times Editorial Team  · 
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